The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints from this lot.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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It was reported that the procedure was performed to treat a moderately tortuous and moderately calcified lesion in the left main artery.Following pre-dilatation with a 3.0x15mm trek balloon dilatation catheter (bdc), a 3.5x28mm xience sierra stent was deployed.A 4.0x8mm nc trek rx bdc was being advanced through the guiding catheter for post-dilatation; however, resistance with the anatomy was felt.The bdc was carefully removed, but resistance with the guide catheter was felt and it was noted that the proximal shaft was kinked.The procedure was successfully completed by post-dilating with a 3.75x15mm nc trek bdc.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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